Duns Number:111598708
Device Description: Repose Mattress Overlay is designed for use on a standard single mattress, where it is pro Repose Mattress Overlay is designed for use on a standard single mattress, where it is proven to provide effective pressure redistribution. Suitable for use in both acute and community settings, Repose Mattress Overlay comes packaged inside a unique and easy to use pump, which enables the mattress overlay to be inflated ready for use within seconds, and the smart valve ensures that the product is inflated to the optimal pressure.
Catalog Number
6011100
Brand Name
Repose Mattress Overlay
Version/Model Number
6011100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKY
Product Code Name
Mattress, Flotation Therapy, Non-Powered
Public Device Record Key
cc07a1d9-27a1-44d9-8179-295c2d500b06
Public Version Date
April 02, 2021
Public Version Number
1
DI Record Publish Date
March 25, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 66 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |